Impact of Simulation Training for Obstetrics-gynecology Residents.
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| ClinicalTrials.gov Identifier: NCT03848975 |
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Recruitment Status :
Recruiting
First Posted : February 21, 2019
Last Update Posted : May 10, 2021
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The main objective of the study is to evaluate the benefit of simulator training for learning external cephalic version (ECV) or vacuum assisted vaginal delivery (hereafter vacuum extraction [VE]) for obstetrics-gynecology residents.
The primary outcome of this randomized control trial is to evaluate the impact of simulation training on the success of ECV and VE.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Simulation Training | Other: Simulation training for ECV Other: Simulation training for VE | Not Applicable |
Usually, the training of obstetrical maneuvers are done "one the job" according to the situations encountered in the clinical practice during postgraduate training. This has some disadvantages like inequality of exposure to these situations, inadequate learning environment (emergencies, impossibility to repeat the maneuver, etc.) and risk complications related to the learner'slack of experience. To evaluate the benefit for learning external cephalic version (ECV) or vacuum assisted vaginal delivery (hereafter vacuum extraction [VE]), the investigators are conducting a randomized control trial composed by two parallel studies. Each group will represent the control group in relation to the maneuver to which it will not be trained.
The objectives of the first one is to evaluate the impact of simulation training on the success of ECV, the complication rate, as well as the patient's and learner's satisfaction. The objectives of the second one is to evaluate the impact of simulation training on the success of VE, the complication rate, as well as the patient's and learner's satisfaction.
The overall goal is to evaluate the effects on clinically relevant outcomes of the teaching by simulation in obstetrics. If simulation training improves the success rate of these maneuvers and the satisfaction of the patient and the learner, simulation learning will be included in a formal and systematic way during postgraduate training in obstetrics.
The subjects are the resident doctors or consultants who have had no or few prior simulation training (maximum 1 session) and little clinical experience of the maneuver evaluated (maximum of 19 of each maneuver).
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 68 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Intervention Model Description: | For the intervention (trained) group, training sessions will be conducted over six months. The control group will learn obstetric maneuver during daily clinical practice in the delivery room under supervision (usual resident training without simulation sessions). The groups will "cross-over" for the next 6 months. After six months the success rate and secondary outcomes will be analyzed. The comparison will be, first, between the intervention (trained) group and the control group and, second, for each subject, between its success rate reported before and its success rate after the observation period. Some aspects of our study design can be those of a cross over trial, or a stepped wedge design : the participants will have intervention ECV followed, after 6 months, by intervention VE, or intervention VE followed, after 6 months, by intervention ECV. However as some aspects are not those of the above designs, the investigators believe that the best category is a parallel trial. |
| Masking: | None (Open Label) |
| Masking Description: | The person who generate the randomization list and prepare the envelopes will not be involved later in the study. The subject of this study necessarily involves the fact that the participants know the group to which they are assigned. They will be asked to avoid to reveal their allocation to the other care providers (midwives and other colleagues) involved in the care of the patients delivering under their supervision. The investigator responsible for collecting and coding the data will not know to which group belongs the person being evaluated. In some cases, the midwife in charge of the patient will collect the data. She will not know to which group belongs to the person being evaluated. The patient will not know to which group belongs the doctor practicing the obstetric maneuver. However the study taking place within a hospital, it can not be excluded that a care provider or an outcome assessor learns informally the allocation of one or more participants, despite these precautions. |
| Primary Purpose: | Other |
| Official Title: | Impact of Simulation Training on the Success Rate of External Cephalic Version and Vacuum Assisted Delivery in Clinical Practice. A Randomized Controlled Trial. |
| Actual Study Start Date : | August 28, 2018 |
| Estimated Primary Completion Date : | November 1, 2022 |
| Estimated Study Completion Date : | November 1, 2022 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Simulation training for ECV
For the intervention (trained) group, the training sessions will be conducted over six months. During this period participants will continue their daily clinical practice in the delivery room: when one of these maneuvers is needed, a case report form (CRF) will be completed by the participant. This group is the Control group for VE : The control group will learn obstetric maneuver during daily clinical practice in the delivery room under supervision (usual resident training without simulation sessions). When one of these maneuvers is needed, a case report form (CRF) will be completed by the participant.
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Other: Simulation training for ECV
Intervention for the ECV group is a ECV simulation training. The group will have theoretical courses and five simulation sessions with four ECV simulation on a model (i.e., a total of 20 ECV), associated with clinical practice in the delivery room. |
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Experimental: Simulation training for VE
For the intervention (trained) group, the training sessions will be conducted over six months. During this period participants will continue their daily clinical practice in the delivery room: when one of these maneuvers is needed, a case report form (CRF) will be completed by the participant. This group is the the control group for for ECV : The control group will learn obstetric maneuver during daily clinical practice in the delivery room under supervision (usual resident training without simulation sessions). When one of these maneuvers is needed, a case report form (CRF) will be completed by the participant.
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Other: Simulation training for VE
Intervention for the VE group is a simulation training. The group will have theoretical courses and five simulation sessions with four VE simulation on a model (i.e., a total of 20 VE), associated with clinical practice in the delivery room. The investigators will us Kiwi® Omni Cup Vacuum Delivery System, as this is the vacuum system chosen for clinical practice in our obstetric service. |
- Success rate of the ECV in the participant clinical practice [ Time Frame: 6 months ]The success of the procedure is defined as the passage of the fetus from a breech ou transverse presentation to a cephalic presentation, immediately confirmed by ultrasound, after a maximum of 2 trials. The outcomes for each procedure (success or not) will be judged at the end of the procedure
- Success rate of the VE in the participant clinical practice [ Time Frame: 6 months ]The success rate of the procedure is defined as birth after vacuum-assisted delivery without release of the Kiwi cup. The cup's release is considered when total and involuntary loss of vacuum occurs, resulting in a loss of contact with the head. If the patient gives birth spontaneously after a vacuum release or if there is a change of instrumentation (following a release or not), it is a failure in the context of this study. The outcomes for each procedure (success or not) will be judge at the end of the procedure
- Reason for stopping ECV [ Time Frame: 6 months ]That is : success, patient request, transmission to supervisor, maximum number of trials reached
- Maximum pain during ECV on numeric rating scale [ Time Frame: 6 months ]Maximum pain during the procedure, reported by the women, using a the numeric rating scale. The scale is composed of 0 (no pain at all) to 10 (worst imaginable pain)
- Maternal satisfaction after the ECV on numeric rating scale [ Time Frame: 6 months ]Global satisfaction reported by the women 2 hours after the ECV using a the numeric rating scale. The scale is composed of 1 (very unsatisfied) to 10 (very satisfied)
- Participant satisfaction after the ECV on numeric rating scale [ Time Frame: 6 months ]Global satisfaction reported by the participant after the ECV using a the numeric rating scale. The scale is composed of 1 (very unsatisfied) to 10 (very satisfied)
- Rate of complication (ECV) [ Time Frame: 6 months ]That is : bleeding, suspicious or pathological cardiotocography (see appendix 1), Kleihauer> 1, retro-placental hematoma, reported in the hour following the ECV
- Rate of emergency cesarean section (ECV) [ Time Frame: 6 months ]Rate of emergency cesarean section performed in case of ECV complication
- Reason for stopping VE [ Time Frame: 6 months ]That is : success, release, transmission to supervisor
- Number of pull for VE [ Time Frame: 6 months ]Number of pull on the Kiwi® Omni Cup Vacuum Delivery System necessary for birth
- Maternal satisfaction after the VE on numeric rating scale [ Time Frame: 6 months ]Global satisfaction reported by the women 2 hours after the VE using a the numeric rating scale. The scale is composed of 1 (very unsatisfied) to 10 (very satisfied)
- Participant satisfaction after the VE on numeric rating scale [ Time Frame: 6 months ]Global satisfaction reported by the participant after the VE using a the numeric rating scale. The scale is composed of 1 (very unsatisfied) to 10 (very satisfied)
- Rate of complication (VE) [ Time Frame: 6 months ]That is : subdural hematoma, subgaleal or intracranial hemorrhage, skull fracture, fetal scalp laceration, third- or four-degree perineal tear, vaginal tear)
- Rate emergency cesarean section rate (VE) [ Time Frame: 6 months ]Rate of emergency cesarean section performed and indication
- Cup position (VE) [ Time Frame: 6 months ]The investigators will document with a picture of the newborn's skull the area where the cup was placed to determine if the placement of the cup was correct. The photos will then be reviewed by the investigator and the position will be judged correct or incorrect. The correct positioning rate will be calculated
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Being a resident or consultant working in the gynecology and obstetrics department of the hospital
- Agreeing to participate in the study by signing an informed consent form
Exclusion Criteria:
- Having performed several ECV or VE simulation training (more than 1 session each) before the recruitment
- Having already performed more than 20 ECV and more than 20 VE during clinical practice before recruitment.
- Having a planned clinical activity in the delivery room which does not allow to perform at least 1 ECV or 1 VE during the study period.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03848975
| Contact: Lorraine Grangier, MD | +41795535019 | lorraine.grangier@hcuge.ch | |
| Contact: Bénédicte LeTinier, MD | +41795530127 | Benedictine.leTinier@hcuge.ch |
| Switzerland | |
| Gynecology & obstetrics department of Geneva University Hospital (Hôpitaux Universitaires de Genève (HUG) | Recruiting |
| Geneva, Switzerland, 1211 | |
| Contact: Lorraine Grangier, MD +417895535019 lorraine.grangier@hcuge.ch | |
| Contact: Bénédicte LeTinier, MD +41795530127 Benedictine.leTinier@hcuge.ch | |
| Principal Investigator: Nicole Jastrow-Meyer, MD,PD | |
| Sub-Investigator: Lorraine Grangier, MD | |
| Sub-Investigator: Bénédicte LeTinier, MD | |
| Sub-Investigator: Michel Boulvain, Prof | |
| Sub-Investigator: Véronique Othenin-Girard | |
| Responsible Party: | Nicole Jastrow Meyer, Principal investigator, University Hospital, Geneva |
| ClinicalTrials.gov Identifier: | NCT03848975 |
| Other Study ID Numbers: |
2016-00310 |
| First Posted: | February 21, 2019 Key Record Dates |
| Last Update Posted: | May 10, 2021 |
| Last Verified: | May 2021 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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Simulation training Obstetrics External cephalic version Vacuum assisted delivery |